The American drugmaker Pfizer has applied to the US health regulators for an Emergency Use Authorization (EUA) for its COVID-19 vaccine, marking a first significant step towards providing protection against the novel coronavirus.
The application to the US Food and Drug Administration (FDA) comes just days after final trial results were announced by Pfizer and German partner BioNTech, which revealed that the vaccine was 95 percent successful in preventing COVID-19 without any significant safety concerns.
In a video posted on the company’s website, Pfizer Chief Executive Officer Albert Bourla confirmed that the application has been made.
The FDA said it would hold an advisory committee meeting on December 10 at which the vaccine would be discussed by members. While both Pfizer and US Health Secretary Alex Azar have said that the FDA could approve the vaccine in mid-December, the agency declined to estimate how long its review would take.
The shares of Pfizer closed up 1.4 percent and the shares of BioNTech ended up 9.6 percent higher, as the prospect of a vaccine soon boosted expectations for the end of a pandemic that has infected almost 55.6 million people worldwide.
The application also includes safety data on around 100 children between the ages of 12-15. 45 percent of US trial participants are 56-85 years old, the company said.
If the data is solid, “we literally could be weeks away from the authorization of a 95% effective vaccine,” Mr. Azar said.
The companies expect the FDA to grant the EUA by mid-December and said they could start shipping doses almost immediately. It is estimated to have 50 million vaccine doses ready this year, enough to cover 25 million people, Pfizer has said.
The final results from the trial showed that the vaccine offered a similar level of protection across various ages and ethnicities which is a promising finding as the disease affects the elderly and minorities disproportionately.
Of the 170 volunteers who contracted COVID-19 in the Pfizer study which involved more than 43,000 individuals, only 162 had received a placebo, indicating that the vaccine was 95 percent effective, much higher than originally anticipated. The US FDA has set a minimum efficacy bar of 50 percent.
Almost 42% of global participants and 30% of US participants in the Phase 3 study have racially and ethnically diverse backgrounds, Pfizer said.
“Filing in the US represents a critical milestone in our journey to deliver a COVID-19 vaccine to the world and we now have a more complete picture of both the efficacy and safety profile of our vaccine,” Mr. Bourla said in a statement.
Another American pharmaceutical firm Moderna is expected to be the next in line to seek a COVID-19 vaccine emergency use approval in the US. The vaccine was found to be 94.5% effective based on an initial review of data from its late-stage trial. Final results and safety data are expected in the coming days or weeks.
It is based on a new technology that both Pfizer-BioNTech and Moderna vaccines work on order to activate an immune response known as synthetic messenger RNA or mRNA that can be produced much faster than on a traditional scale.
The next late-stage data from AstraZeneca, which is collaborating with the University of Oxford, is expected to come in November or December. US-based Johnson & Johnson said it expects to have the data needed to obtain US approval for its experimental vaccine by February.
Dozens of other drugmakers from across the world are rushing to find a prevention for the devastating virus.